Advanced Prostate Cancer Treated with Intermittent or Continuous Androgen Deprivation in the Randomised FinnProstate Study VII: Quality of Life and Adverse Effects

Background: Intermittent dosing may reduce the adverse events (AEs) of androgen-deprivation therapy (ADT). Objective: To compare intermittent androgen deprivation (IAD) and continuous androgen deprivation (CAD) with regard to health-related quality of life (QoL). Design, setting, and participants: A total of 852 men with advanced prostate cancer (PCa) were enrolled to receive goserelin acetate 3.6 mg every 28 d for 24 wk. A total of 554 patients whose prostate-specific antigen (PSA) decreased to <10 ng/ml or by >= 50% (<20 ng/ml at baseline) were randomised to IAD or CAD. Intervention: In the IAD arm, ADT was resumed for at least 24 wk whenever PSA increased >20 ng/ml or above baseline. Outcome measurements and statistical analysis: QoL was monitored with a validated Cleary 30-item questionnaire and analysed by the Mann-Whitney U test, 0.5 standard deviation rule, and repeated measures analysis of variance. AEs and adverse drug reactions (ADRs) were analysed by the chi-square test. Results and limitations: Median follow-up was 65 mo. Significant differences in QoL emerged in activity limitation, physical capacity, and sexual functioning, favouring IAD. No significant differences emerged in the prevalence of AEs: 87 patients in the IAD arm (31.8%) and 95 in the CAD arm (33.9%) had cardiovascular (CV) AEs (p = 0.59), with 25 (9.1%) and 29 (10.4%) withdrawn (p = 0.62), and 21 (7.7%) and 24 (8.6%) dying because of a CV event (p = 0.70), respectively; bone fractures occurred in 19 (6.9%) and 15 (5.4%) patients (p = 0.44), respectively. Hot flushes or night sweats were the most common ADRs (47.1% vs 50.4%; p = 0.44). Erectile dysfunction (15.7% vs 7.9%; p = 0.042) and depressed mood (2.2 vs 0%; p = 0.032) were more common in the IAD arm. Conclusions: IAD showed benefits in the treatment of advanced PCa with respect to QoL. The prevalence of AEs was not significantly lower with IAD. Trial registration: ClinicalTrials.gov, NCT00293670. (C) 2012 European Association of Urology. Published by Elsevier B. V. All rights reserved.